NATURAL HEALTH PRODUCT

OLIGOTHERAPY

This monograph is intended to serve as a guide to industry for the preparation of Product Licence
Applications (PLAs) and labels for natural health product market authorization. It is not intended
to be a comprehensive review of the medicinal ingredients.

Notes
By submitting a PLA referencing this monograph, the applicant is attesting that the product
will comply fully with the recommended conditions of use outlined in this monograph. The
conditions of use include methods of preparations, source materials, doses, durations of use,
combinations of medicinal ingredients, and risk statements.
Text in parentheses is additional optional information which can be included on the PLA and
product label at the applicants discretion.
The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or
statement may be selected by the applicant.
The use of the electronic Product License Application form (ePLA) is not possible for
products associated with this monograph.

Date June 24, 2013

Proper name(s), Common name(s), and Source material(s)

Please refer to Table 1 and 2 below.

Route(s) of administration

Oral
Sublingual

Dosage form(s)

The acceptable pharmaceutical dosage forms include, but are not limited to capsules,
chewables (e.g. gummies, tablets), liquids, powders, strips or tablets.
This monograph is not intended to include foods or food-like dosage forms such as bars,
chewing gums or beverages.
The acceptable pharmaceutical dosage forms suited to sublingual administration.

Use(s) or Purpose(s) Statement(s) to the effect of

Oligotherapy preparation/remedy/medicine

Dose(s) Statement(s) to the effect of

Subpopulation(s)

Adults ( 18 years)

Quantity(ies)

All products except those specified below

1 dosage unit, 1-2 times per day.

Dosage information for specific single ingredient products:

Products containing only Bismuth as a medicinal ingredient

1 dosage unit every 3 hours up to 8 times per day for 3-5 days.

Products containing Cobalt as a medicinal ingredient

1 dosage unit per day.

Products containing only Copper as a medicinal ingredient

1 dosage unit every 3 hours up to 8 times per day for 3-5 days.

Products containing only Iodine, Iron, Magnesium, Phosphorus or Zinc as a medicinal

ingredient

1 dosage unit, 1-2 times per day

Dosage information for specific multi-ingredient products:

Products containing only Zinc and Copper in combination as medicinal ingredient

1 dosage unit, 1-2 times per day

Products containing Copper, Gold and Silver in combination as medicinal ingredients

1 dosage unit, 1-2 times per day.

Table 1 Proper name(s), Common name(s), Source material(s) and Dosage information
for single ingredient preparation
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 Maximum quantity
Proper Common
Source material(s) per dosage unit
name(s) name(s)
(g)

Aluminium Aluminium Aluminium gluconate 176

Bismuth Bismuth Bismuth gluconate 70

Cobalt Cobalt Cobalt gluconate 59

25
Chromium Chromium Chromium (III) chloride

Copper Copper Copper gluconate 725.2

Fluoride Fluoride Sodium fluoride 200

Sodium iodide; 24
Iodine Iodine
Potassium iodide

Iron Iron Iron gluconate 14

Magnesium Magnesium Magnesium gluconate 104.4

Manganese Manganese Manganese gluconate 72.8

Nickel Nickel Nickel gluconate 72.6

Phosphorus Phosphorus Disodium phosphate 140

Potassium Potassium Potassium gluconate 40

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 Maximum quantity
Proper Common
Source material(s) per dosage unit
name(s) name(s)
(g)

Selenium Selenium Selenite sodium 100

Sulphur Sulphur Sodium thiosulfate 122

Zinc Zinc Zinc gluconate 67.4

Table 2 Proper name(s), Common name(s), Source material(s) and Dosage information
for multi-ingredient preparation containing one of the following combination

Quantity per dosage

Proper Common
Source material(s) unit
name(s) name(s)
(g)

Manganese; Manganese; Manganese gluconate; 72.8;

Cobalt Cobalt Cobalt gluconate 72.6
Manganese; Manganese; Manganese gluconate; 72.8;
Copper; Copper; Copper gluconate; 72.6;
Cobalt Cobalt Cobalt gluconate 72.6
72.8 mcg;
Manganese; Manganese; Manganese gluconate; 72.8;
Copper Copper Copper gluconate 72.6
Cobalt; Cobalt; Cobalt gluconate Nickel 72.6;
Nickel Nickel gluconate; 72.6
Copper; Copper; Copper gluconate; Zinc 72.6;
Zinc Zinc; gluconate 67.4
Cobalt; Cobalt; Cobalt gluconate; 72.6;
Nickel; Nickel; Nickel gluconate; 72.6;
Zinc Zinc Zinc gluconate 67.4
Copper; Copper; Copper gluconate; 31;
Gold; Gold; Gold elemental; 98;
Silver Silver Silver gluconate 50
Copper; Copper; Copper gluconate; 63;
Gold; Gold; Gold elemental; 1.4;
Silver Silver Silver gluconate 21.36

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 Copper; Copper; Copper gluconate; 500;
Gold; Gold; Gold elemental; 0.2;
Silver Silver Silver gluconate 7.4

Directions for use

All product

Take as directed by a health care practitioner.

Products containing Iron or Zinc

Take a few hours before or after taking other medications (HC 2012; Martindale 2011).
Take with food (HC 2012; Martindale 2011).

Duration of use Statement(s) to the effect of

Use for up to two months or as recommended by a health care practitioner (Brigo 1999).

Risk information Statement(s) to the effect of

Cautions and warnings

All products

If symptoms persist or worsen, consult a health care practitioner.

If you are pregnant or breastfeeding, consult a health care practitioner prior to use.

Products containing Aluminium

If you have renal impairment, consult a health care practitioner prior to use (JECFA 1988)

Products containing Cobalt

If you are taking Vitamin B12, consult a health care practitioner prior to use (EVM 2003)
If gastrointestinal upset and/or skin rashes occur, discontinue use and consult a health care
practitioner.

Products providing doses of Selenium 200 g per day

If you have a history of non-melanoma skin cancer, consult a health care practitioner prior to use.

Contraindications

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Products containing Cobalt

If you have an iodine deficiency, do not use this product (EVM 2003).

Products containing Manganese

If you have tuberculosis or a history of tuberculosis, do not use this product (Padrazzi 1988;
Mntrier 1983).

Products containing Manganese and Cobalt

If you have tuberculosis or a history of tuberculosis, do not use this product (Mntrier 1983).

Products containing Zinc and/or Copper

If you have cancer, tuberculosis or a history of tuberculosis, do not use this product (Padrazzi
1988; Mntrier 1983).

Known adverse reactions

Products containing Fluoride

Using this product in an area where the drinking water has a natural fluorine content in excess of
0.7 parts of fluoride ion per million parts of water or is artificially fluoridated, may result in
mottling of the tooth enamel.

Non-medicinal Ingredients

Must be chosen from the current NHPD Natural Health Products Ingredients Database (NHPID)
and must meet the limitations outlined in the database.

Specifications

The finished product specifications must be established in accordance with the requirements
described in the NHPD Quality of Natural Health Products Guide.
The medicinal ingredient must comply with the requirements outlined in the Natural Health
Products Ingredients Database (NHPID).

References reviewed

ANSM 2012: Agence nationale de scurit du mdicament et des produits de sant. [Accessed
2013 May 29]. Available from: http://afssaps-prd.afssaps.fr/php/ecodex/index.php

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ASHP 2005: American Society of Health-System Pharmacists. American Hospital Formulary
Service (AHFS) Drug Information. Philadelphia (PA): Lippincott Williams and Wilkins; 2005.

Brigo, B. Logique thrapeutique des Oligolments et des remdes en lithothrapie. Collection

Rsurgence. (LU): Marco Pietteur, diteur, 1999.

Chappuis P. Favier A. Les oligolments en nutrition et en thrapeutique. (FR): Lavoisier, 1995.

Douart, JP. LOligothrapie en pathologie fonctionnelle: Donnes scientifiques et cliniques.

(FR): ditons Maloine, 1994.

Dupouy A. Oligothrapie: Prcis de Clinique et de thrapeutique. (FR): ditions Maloine, 1988.

EC 2009: European Commision. Scientific Committee on Cosmetic Products (SCCP), Health &
Consumer Protection, Directorate-General. Clarificaton on the opinions SCCNFP/0653/03 and
SCCP/0882/05 on the safety of fluorine compounds in oral hygiene products for children under
the age of 6 years. [Accessed 2013 May 29]. Available from:
http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_169.pdf

EVM 2003: Expert Group on Vitamins and Minerals. Safe Upper Levels for Vitamins and
Minerals. May 2003. [Accessed 2013 May 29]. Available from:
http://cot.food.gov.uk/pdfs/vitmin2003.pdf

Greaves M. Gemmotherapy and Oligotherapy Regenerators of Dying Intoxicated Cells.

(US):Xlibris, 2002.

Martindale 2011: Sweetman SC, editor. Martindale: The Complete Drug Reference. 37th edition
[Internet]. London (GB): Pharmaceutical Press; 2012. [Accessed 2013 May 29]. Available from:
http://www.medicinescomplete.com

Mntrier J. La mdecine des fonctions, deuxime dition. (FR): Hemsi, 1983.

Padrazzi P. Fatigue et oligo-lments. (FR): ditions Similia, 1997.

Padrazzi P. Loligothrapie ractionnelle. (FR): ditions Similia, 1988.

Picard H. Utilisation thrapeutique des oligo-lments, 5e dition. (FR): ditions Maloine, 1986.

Sal J., Donadieu Y. Les thrapeutiques naturelles : les oligolments. (FR): ditions Maloine,
1986.

Simon V. Les troubles fonctionnels et leur traitement. (FR): ditions Maloine, 2002.

U.S. Food and Drug Administration, Food and Drugs, Food and Drug Administration Department
of Health and Human Services, Drugs for Human Use. Part 369 - Interpretative Statements Re

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Warnings on Drugs and Devices for Over-The-Counter Sale. [Accessed 2013 May 29]. Available
from: http://www.gpo.gov/fdsys/

U.S. Food and Drug Administration, Food and Drugs, Food and Drug Administration Department
of Health and Human Services, Drugs for Human Use. Part 355 Anticaries Drug Products For
Over-The-Counter Human Use. [Accessed 2013 May 29]. Available from:
http://www.gpo.gov/fdsys/

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